Fibrocystic breast condition, also referred to as mammary dysplasia, benign breast condition, and diffuse cystic mastopathy, is a benign condition, generally in pre-menopausal women, characterized by the presence of lumps or cysts in the breasts. The condition is fairly common; approximately 60% of women are estimated to have experienced fibrocystic breast condition at some point in their lives. The condition may, for example, be accompanied by pain or discomfort in one or both breasts, tenderness, swelling, breast thickness. The condition can cause extreme discomfort, and can also make the detection of breast cancer more difficult.
The specific cause of fibrocystic breast condition and accompanying changes in the breasts isn't fully understood, although it is believed that estrogen and other reproductive hormones play a role. The occurrence of symptoms may be cyclical or non-cyclical (many women experience symptoms just prior to menstruation). Commonly recommended treatments include administration of over-the-counter pain relievers such as ibuprofen or acetaminophen, application of warm or cold compresses, administration of estrogen or other hormones, fine-needle aspiration for removing fluid from fluid-filled cysts or surgical removal if warranted, and modification of diet. Additional alternative approaches have been suggested for relieving the symptoms of fibrocystic breast condition including the implementation of a vegetarian diet, limiting the intake of caffeine, implementing a low-fat diet, and intake of dietary supplements and herbal remedies such as dandelion leaf, cleavers, and yarrow. Topical approaches include the application of poke root oil or a gel or cream of natural progesterone to the breasts. At present, there does not appear to be consensus amongst the members of the medical community regarding effective therapies for treating fibrocystic breast condition.
One supplement that has been suggested for treating fibrocystic breast condition, among other conditions, is iodine. The use of iodine is complicated by its administration in many different forms. Iodine may be delivered as organically-bound iodine (e.g., caseinated iodine), inorganic iodine, and molecular iodine, i.e., I2; each of these forms of iodine has been used to treat conditions in addition to fibrocystic breast condition such as iodine deficiency, goiter, hypothyroidism, etc. Some ingestible iodine compositions include iodide salts having no mechanism for efficient conversion of iodide to molecular iodine prior to absorption into internal tissue. Other compositions include an unstable form of molecular iodine that reacts to form iodide salts prior to significant interaction with internal tissue. Examples of iodide salts include potassium iodide and sodium iodide, both of which are used in iodized salt in many countries. Iodide (CAS Registry Number: 20461-54-5) and molecular iodine (CAS Registry Number: 7553-56-2) differ significantly in their chemical nature and physiologic interactions with the human body. Iodide (typically administered with a suitable counter-ion) has an anionic charge and is hydrophilic, stable in water, and is also highly water soluble, whereas in contrast, molecular iodine is uncharged and hydrophobic, and reacts rapidly with water, making it unstable at pH values above 6.0.
Significant differences also exist between iodide and molecular iodine in terms of the toxicity and therapeutic efficacy of orally administered forms thereof (K. D. Thrall, Ph.D. dissertation, Washington State University, Program in Pharmacology and Toxicology, December 1990). Despite the differences in pharmacologic and toxicological activity between molecular iodine and iodide as noted above, the term “iodine” is frequently used interchangeably to refer to these two species, as well as to several other distinct chemical species that contain iodine atoms. Iodide salts are frequently simply described as iodine due to the fact that the iodide salts contain ionic forms of atomic iodine. Much of the prior art, including the scientific medical literature, uses the term “iodine” somewhat imprecisely in this regard.
Human consumption of iodide at levels of 0.150 to 1.1 mg per day has been established as safe for the general population by FDA researchers (J. A. Pennington, “A review of iodine toxicity reports,” J. Am. Dietetic Assoc., Vol. 90, Number 11, pp. 1571-1581 1990). Above this level, the primary safety concern is the thyroid organ. There are discrete patient populations that have an elevated risk of experiencing thyroid-related adverse events when exposed to daily supraphysiological iodine above the levels described above.
In a Phase II clinical study, dosing with a molecular iodine-based dosage form as described in U.S. Pat. Nos. 5,885,592 and 6,248,335 was demonstrated as a safe and effective treatment for treating symptoms related to fibrocystic breast condition. However, there remains a need for dosage forms and related therapies for treatment of fibrocystic breast condition that can deliver supraphysiological doses of iodine in an amount effective to result in a notable reduction in one or more symptoms associated with fibrocystic breast condition, and that are effective and safe for rapidly establishing normal thyroid function in those individuals who are deficient in key nutritional cofactors.